Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia

NCT ID: NCT06239207

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-21
• Study Completion Date: 2024-07-21

Brief Summary

Androgenetic alopecia is a common condition affects both genders. Patients of androgenetic alopecia following inclusion criteria will be enrolled after ethical approval and informed consent. Pre-treatment assessment will be done by Physian Global assessment, Patient global assessment and hair density by trichoscopy of areas under treatment. Patients will be categorized in 2 groups. Group A receiving exosomes 1session intradermally in scalp after nerve block and group B receiving PRP 2 sessions of PRP 1 month apart intradermally in scalp after nerve block. Patients will receive exosomes at strength of 2 to 10 billion particles/5ml with 0.1 ml/cm2. Follow up will be done after 1 month, 2 months, 3 months, 5 months and 6 months of completion of treatment to assess hair growth and reduce hair fall by Physian Global assessment (PGA), Patient global assessment (PtGA) and trichography. Clinical response will be graded as satisfactory (< 25%), good (25-50%) or excellent (> 50%) improvement. Details will be entered on predesigned proforma. Data will be entered and analyzed using SPSS 27. Means will be calculated for quantitative variables, frequencies for qualitative variables like pre- and post treatment response. Data will be stratified for role of effect modifiers

Detailed Description

Androgenetic alopecia (AGA) is a common condition that affects up to 50 percent of males and females. It is characterized by progressive loss of terminal hair of the scalp any time after puberty. It has a very typical distribution in both males and females. In males, hair loss is mostly on vertex and frontotemporal regions, while in women the frontal hairline is mostly involved with diffuse hair loss at the crown and top of head. Currently, FDA approved treatments are topical minoxidil and oral finasteride. But due to its adverse effects, most patients refuse to take this drug. Platelet rich plasma (PRP) is currently effective alternate therapy used very commonly. PRP is autologous concentration of platelets, having multiple growth factors in their alpha granules, injected intradermally in scalp. There is another emerging treatment modality which is exosomes. Exosomes are 30-150nm extracellular vesicles (EVs) derived from various mesenchymal stem cells (MSCs). Exosomes contain various proteins, nucleic acids and various cell mediators and growth factors. They have same biological properties as that of their parent derived cell along with advantages of small size, easy penetration of biological membranes, low immunogenicity, easy storage, and no tumorization. Recently, exosomes have been genetically modified so that they can exhibit better therapeutic properties, such as enriched active ingredients, targeted delivery, and physiological barrier to penetration. Because of their properties they have roll in hair growth. Exosomes are providing promising results in patients of androgenetic alopecia. Both PRP and exosome therapy has found to be effective in various studies across the globe. Very less literature is found on comparison of these two treatment modalities specially in the world.

Learning Objective is to compare the efficacy and safety of PRP and Exosomes in patients of Androgenetic alopecia.

It is a randomized clinical trial going on in Dermatology department of Services hospital Lahore, Pakistan. After getting approval from Ethical Review Board.

Pre-treatment assessment is done by hair pull test, global physician assessment, patient global assessment and hair density by trichoscopy of the involved areas of scalp. The patients are randomized into two groups by paper lottery method. After regional nerve block under aseptic conditions, Group A patients are injected exosomes intradermally at a strength of 2 to 10 billion particles/5ml, at a dose of 0.1 ml/cm2 of scalp, and group B patients are injected PRP intradermally in scalp. Exosomes used are GFCCELLTM EXO SCALP KIT. PRP is prepared under aseptic precautions, around 10ml of blood is collected from the median cubital vein and is transferred into a sodium citrate tube. Then the tubes are rotated in a centrifuge machine at 1500 RPM for 10 minutes. This first centrifugation is called "soft spin," which separates the blood into 2 layers: the lower RBC layer; the upper acellular plasma layer which is further subdivided into an upper layer which contains platelet poor plasma and a lower layer which contains platelet rich plasma also known as the buffy coat. The buffy coat along with the plasma was collected with a pipette and transferred into another test tube. This tube was again subjected to a second centrifugation at 4000 RPM for 10 minutes, called "hard spin." This allows the platelets to settle at the bottom of the tube. Both the upper layer containing platelet poor plasma and the lower layer of the PRP was collected in another clean tube. The plasma is filled into insulin syringe and then injected evenly into the affected areas of the scalp. Multiple PRP injections of 0.1 mL were given at each site in a linear pattern 1 cm apart. The patients are followed monthly after the first treatment session for 6 months. The primary efficacy endpoints of this study are increse in hair regrowth assessed by Global physician assessment and patient global assessment on scale of three ( <25% as satisfactory, 25-50% as good response, >50% as excellent response) and number of hairs which are calculated by trichoscopy. Demographic data and pretreatment parameters are recorded on a predesigned proforma. Data is entered and analyzed using SPSS vs 20.

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exosomes

Group A patients are injected exosomes 2 session 3 months apart, intradermally at a dose of 0.1 ml/cm2 of scalp. Exosomes used are GFC CELL(TM) EXO SCALP KIT

Group Type: EXPERIMENTAL

Exosomes GFC CELL EXO SCALP KIT (Leuco Exo 97%)

Intervention Type: BIOLOGICAL

Exosomes used are GFC CELL, consist of Leuco exo 97% having GFC CELL EXO SCALP 9700 powder and EXO SCALP Pep9 solution

B PRP

PRP 4 sessions 1 months apart. Group B patients are injected PRP intradermally in scalp. Uunder aseptic around 10ml of blood is collected from the median cubital vein and is transferred into a sodium citrate tube. Then the tubes are rotated in a centrifuge machine at 1500 RPM for 10 minutes.It separates the blood into 2 layers: the lower RBC layer; the upper plasma layer buffy coat. The buffy coat was transferred into another test tube. This tube was again subjected to a second centrifugation at 4000 RPM for 10 minutes. Both the upper layer containing platelet poor plasma and the lower layer of the PRP was collected. The plasma is filled into insulin syringe and then injected evenly into the affected areas of the scalp. Multiple PRP injections of 0.1 mL were given at each site in a linear pattern 1 cm apart

Group Type: ACTIVE_COMPARATOR

Platelet Rich Plasma

Intervention Type: BIOLOGICAL

PRP is prepared under aseptic precautions, around 10ml of blood is collected in PRP tubes which are rotated in a centrifuge machine at 1500 RPM for 10 minutes. Which separates the blood into 2 layers: the lower RBC layer; the upper acellular plasma layer. The buffy coat along with the plasma was collected with a pipette and transferred into another test tube underwent 2nd spin at 4000 RPM for 10 min. This PRP was collected in another clean tube to be used as plasma

Interventions

Exosomes GFC CELL EXO SCALP KIT (Leuco Exo 97%)

Exosomes used are GFC CELL, consist of Leuco exo 97% having GFC CELL EXO SCALP 9700 powder and EXO SCALP Pep9 solution

Intervention Type: BIOLOGICAL

Platelet Rich Plasma

PRP is prepared under aseptic precautions, around 10ml of blood is collected in PRP tubes which are rotated in a centrifuge machine at 1500 RPM for 10 minutes. Which separates the blood into 2 layers: the lower RBC layer; the upper acellular plasma layer. The buffy coat along with the plasma was collected with a pipette and transferred into another test tube underwent 2nd spin at 4000 RPM for 10 min. This PRP was collected in another clean tube to be used as plasma

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• All patients with androgenetic alopecia
• age from 18 to 70 years
• Sex: male and female

Exclusion Criteria

• Patient with platelets disorders, thrombocytopenia
• Patients using anti-platelet therapy
• Use of pharmacological therapeutics targeting AGA as Finasteride®, use of topical medicines as lotions as Minoxidil®, retinoid, or corticosteroids in the earlier year.
• Patients with bone marrow aplasia, uncontrolled diabetes, sepsis, cancer

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Services Hospital, Lahore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr Alina Abbass

Senior Registrar Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alina Abbass, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Services Institute of medical Sciences

Locations

Services Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB/2023/1181/SIMS

Identifier Type: -

Identifier Source: org_study_id